AMMONIUM FLUORIDE
RestrictedCAS 12125-01-816 regulations across 16 markets
AMMONIUM FLUORIDE is a cosmetic ingredient classified as Antiplaque. Also known as CAS 12125-01-8. It is regulated in 16 markets including UAE, Bahrain, Brazil.
Also Known As
- CAS Number
- 12125-01-8
Market Overview — 29 Markets
European Union1
United Kingdom1
United States
California
Maryland
Washington
Canada
Brazil1
South Korea
Japan
Taiwan1
Australia
Singapore1
Malaysia1
Thailand1
Indonesia1
Vietnam1
Philippines1
UAE1
Saudi Arabia1
Qatar1
Oman1
Kuwait1
Bahrain1
Russia
Belarus
Kazakhstan
Armenia
Kyrgyzstan
Detailed Regulations
Europe2 regulations
European UnionRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
- Product type
- Oral products
- Conditions of use
- Contains ammonium fluoride. For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory: “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
Source: EC 1223/2009 Annex III
United KingdomRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
- Product type
- Oral products
- Conditions of use
- Max: 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % Contains ammonium fluoride. For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. ‘ for adult use only ’ ) the following labelling is obligatory: Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.
Source: UK retained EC 1223/2009 Annex III
Americas1 regulation
BrazilRestricted
- Chemical name
- Fluoreto de amônio
- Max concentration
- a) e b) 0,15% expresso como flúor. Em caso de mistura com outros compostos fluorados permitidos, a concentração máxima total de flúor não excederá 0,15%.
- Product type
- a) Dentifrício b) Enxaguatóri o bucal
- Conditions of use
- Application: a) Dentifrício b) Enxaguatóri o bucal
Source: ANVISA RDC 530
East Asia & Oceania1 regulation
TaiwanRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0.15%(以F計)
- Product type
- Oral products
Source: TFDA Cosmetics Regulations
ASEAN6 regulations
SingaporeRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0.15 %calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
- Product type
- (a) Oral hygiene products (except mouthwash) (b) Mouthwash
- Conditions of use
- (a) & (b) Contains ammonium fluoride. (a) 'Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.' (12) (b) Do not use for children below 6 years of age
Source: ASEAN Cosmetic Directive (HSA Dec 2025)
MalaysiaRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0.15 %calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
- Product type
- (a) Oral hygiene products (except mouthwash) (b) Mouthwash
- Conditions of use
- (a) & (b) Contains ammonium fluoride. (a) 'Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.' (12) (b) Do not use for children below 6 years of age
Source: ASEAN Cosmetic Directive (HSA Dec 2025)
ThailandRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0.15 %calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
- Product type
- (a) Oral hygiene products (except mouthwash) (b) Mouthwash
- Conditions of use
- (a) & (b) Contains ammonium fluoride. (a) 'Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.' (12) (b) Do not use for children below 6 years of age
Source: ASEAN Cosmetic Directive (HSA Dec 2025)
IndonesiaRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0.15 %calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
- Product type
- (a) Oral hygiene products (except mouthwash) (b) Mouthwash
- Conditions of use
- (a) & (b) Contains ammonium fluoride. (a) 'Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.' (12) (b) Do not use for children below 6 years of age
Source: ASEAN Cosmetic Directive (HSA Dec 2025)
VietnamRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0.15 %calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
- Product type
- (a) Oral hygiene products (except mouthwash) (b) Mouthwash
- Conditions of use
- (a) & (b) Contains ammonium fluoride. (a) 'Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.' (12) (b) Do not use for children below 6 years of age
Source: ASEAN Cosmetic Directive (HSA Dec 2025)
PhilippinesRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0.15 %calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
- Product type
- (a) Oral hygiene products (except mouthwash) (b) Mouthwash
- Conditions of use
- (a) & (b) Contains ammonium fluoride. (a) 'Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.' (12) (b) Do not use for children below 6 years of age
Source: ASEAN Cosmetic Directive (HSA Dec 2025)
GCC6 regulations
UAERestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
- Product type
- Oral products
- Conditions of use
- Contains ammonium fluoride. For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory: “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
Source: GSO 1943:2024 (based on EU 1223/2009 III)
Saudi ArabiaRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
- Product type
- Oral products
- Conditions of use
- Contains ammonium fluoride. For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory: “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
Source: GSO 1943:2024 (based on EU 1223/2009 III)
QatarRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
- Product type
- Oral products
- Conditions of use
- Contains ammonium fluoride. For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory: “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
Source: GSO 1943:2024 (based on EU 1223/2009 III)
OmanRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
- Product type
- Oral products
- Conditions of use
- Contains ammonium fluoride. For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory: “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
Source: GSO 1943:2024 (based on EU 1223/2009 III)
KuwaitRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
- Product type
- Oral products
- Conditions of use
- Contains ammonium fluoride. For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory: “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
Source: GSO 1943:2024 (based on EU 1223/2009 III)
BahrainRestricted
- Chemical name
- Ammonium fluoride
- CAS
- 12125-01-8
- Max concentration
- 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
- Product type
- Oral products
- Conditions of use
- Contains ammonium fluoride. For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory: “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
Source: GSO 1943:2024 (based on EU 1223/2009 III)
EAEUNo restrictions
No specific restrictions for AMMONIUM FLUORIDE in Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan.
Frequently Asked Questions
Is AMMONIUM FLUORIDE banned in any country?
AMMONIUM FLUORIDE is not banned in any of the 26 markets tracked by Formpli. However, it may be subject to restrictions or conditions of use in some markets.
What are the restrictions on AMMONIUM FLUORIDE in cosmetics?
AMMONIUM FLUORIDE is restricted or has conditions of use in UAE, Bahrain, Brazil, European Union, Indonesia, Kuwait, Malaysia, Oman, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Taiwan, United Kingdom, Vietnam. Restrictions may include maximum concentration limits, product type limitations, or mandatory labeling requirements. See the detailed regulations above for specifics.
Can I use AMMONIUM FLUORIDE in cosmetics?
AMMONIUM FLUORIDE is regulated in 16 markets. It has restrictions in UAE, Bahrain, Brazil, European Union, Indonesia, Kuwait, Malaysia, Oman, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Taiwan, United Kingdom, Vietnam. Use Formpli's free screening tool to check your full ingredient list against all 26 markets at once.
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Check Ingredients FreeThis information is for reference only and does not constitute legal or regulatory advice. Regulations change — always verify with official sources and consult a regulatory specialist before exporting cosmetic products. Data sourced from EU COSING, US FDA, Health Canada, MHLW Japan, MFDS Korea, ASEAN ACD, GCC SFDA, TGA Australia, ANVISA Brazil, EAEU TR CU, and Taiwan TFDA.